Liver Transplantation (LT)LOVENCT07674394
New Biomarkers for Organ Viability Assessment During Hypothermic Machine Perfusion in Liver Transplantation: the Role of Extemporaneous Histological Examination.
A study testing Hypothermic Oxygenated Machine Perfusion (HOPE/D-HOPE) in people with Liver Transplantation (LT) and Early Allograft Dysfunction, run by The Mediterranean Institute for Transplantation and Advanced Specialized Therapies at 3 sites in Italy.
Trial summary
Liver transplantation is a life-saving treatment for patients with severe liver disease. Because of the shortage of donor organs, transplant centers increasingly use donor livers that may be more vulnerable to injury and dysfunction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Transplantation (LT), Early Allograft Dysfunction, Primary Non-function
- What is being tested?
- Hypothermic Oxygenated Machine Perfusion (HOPE/D-HOPE)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 3 sitesItaly
- Study dates
- Dec 2026to Jun 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult liver transplant recipients (≥18 years of age).
- Donor liver grafts from either Donation after Brain Death (DBD) or Donation after Circulatory Death (DCD).
- Grafts undergoing hypothermic oxygenated perfusion (HOPE) (HOPE or D-HOPE) for a minimum duration of 1 hour prior to transplantation.
- Availability of two wedge liver biopsy samples: one pre perfusion and one post-perfusion.
- Grafts preserved using standard cold storage protocols and transported in ice-cold Servator C™ solution.
- Informed consent obtained from the recipient (or legal representative, where applicable) for the use of clinical and histological data for research purposes.
Who cannot join
- Inadequate or fragmented biopsy samples, preventing proper histological evaluation.
- Biopsy samples showing histological features of pre-existing chronic liver disease (e.g., cirrhosis, autoimmune hepatitis, chronic viral hepatitis).
- Liver grafts subjected to normothermic perfusion or other non hypothermic perfusion techniques.
- Organs undergoing experimental or non-standard perfusion protocols.
- Grafts from donors <18 years of age.
- Recipient refusal or inability to provide informed consent.
- Technical failure during perfusion (e.g., incomplete perfusion due to device malfunction or vascular anomalies).
- Known malignancy in the donor with potential liver involvement, excluding donors with small incidentalomas as per standard guidelines.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Italy3 sites
ASST Grande Ospedale Metropolitano Niguarda
Milan, 20162
IRCCS ISMETT - Istituto Mediterraneo per i Trapianti e le Terapie ad Alta Specializzazione,
Palermo, 90127
Ivan Vella, +39 3803403369, ivella@ismett.edu
Monica Rizzo, +39 0912192692, ufficioricerca@ismett.edu
Azienda Ospedaliera San Camillo Forlanini
Roma, 00152
About this study
Liver transplantation is a life-saving treatment for patients with severe liver disease. Because of the shortage of donor organs, transplant centers increasingly use donor livers that may be more vulnerable to injury and dysfunction. To improve the quality of these organs before transplantation, many centers use hypothermic oxygenated machine perfusion (HOPE or D-HOPE), a technique that preserves the liver under cold, oxygenated conditions. However, there are currently no widely accepted methods to determine whether a liver is functioning well enough during this preservation process.
The purpose of this study is to investigate whether changes observed in liver tissue during hypothermic machine perfusion can help predict how well the transplanted liver will function after surgery. The study will compare liver biopsy samples collected before and after one hour of perfusion and will analyze biological markers released into the perfusion fluid, including markers of mitochondrial injury and inflammation.
Read more
The main question this study aims to answer is whether histological changes occurring during hypothermic perfusion, alone or in combination with biochemical biomarkers, can accurately predict liver graft viability and post-transplant outcomes. Researchers will also evaluate whether these data can be used to develop an artificial intelligence-based model to support clinical decision-making during organ preservation.
A total of 150 adult liver transplant recipients receiving donor livers treated with HOPE or D-HOPE will be enrolled at three Italian liver transplant centers. Participants will be followed for 90 days after transplantation to assess liver graft function, graft survival, patient survival, and post-transplant complications.
The results of this study may improve the assessment of donor liver quality before transplantation and help clinicians make more informed decisions about organ use, ultimately increasing the safety and effectiveness of liver transplantation.
- Conditions
- Liver Transplantation (LT), Early Allograft Dysfunction, Primary Non-function, Ischemia-Reperfusion Injury
- Being tested
- Hypothermic Oxygenated Machine Perfusion (HOPE/D-HOPE)
- Keywords
- liver transplantation, Early Allograft Dysfunction (EAD), Primary Non-Function (PNF), Ischemia-Reperfusion Injury, Liver Graft Viability Assessment
- Medical subject headings
- Reperfusion Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypothermic Oxygenated Machine Perfusion (HOPE/D-HOPE)Procedure or surgery
Standard-of-care hypothermic oxygenated machine perfusion of donor liver grafts before transplantation, with collection of biopsies and perfusate samples for research analyses.
| Study group | Role | What they receive |
|---|---|---|
| HOPE/D-HOPE Liver Transplant Recipients | Experimental | Adult liver transplant recipients receiving donor liver grafts preserved with hypothermic oxygenated machine perfusion (HOPE or D-HOPE) prior to transplantation. Liver biopsies and perfusate samples are collected before and during perfusion for histological and biomarker analyses, and participants are followed for 90 days after transplantation. Receives: Procedure: Hypothermic Oxygenated Machine Perfusion (HOPE/D-HOPE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Graft Survival
Graft survival defined as the absence of Early Allograft Dysfunction (EAD) or Primary Non-Function (PNF) following liver transplantation. Histological changes observed between pre-perfusion and post-perfusion liver biopsies will be evaluated for their association with graft outcomes.
Measured: 90 days after liver transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2026
- Study startDec 2026 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionJun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver Transplantation (LT)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Mediterranean Institute for Transplantation and Advanced Specialized Therapies
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07674394
- Sponsor's protocol ID
- IRRB/13/26
- Acronym
- LOVE
- Status last verified
- Nov 2026
- First submitted
- 23 Jun 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New Biomarkers for Organ Viability Assessment During Hypothermic Machine Perfusion in Liver Transplantation: the Role of Extemporaneous Histological Examination.
- ClinicalTrials.gov ID
- NCT07674394
- Acronym / sponsor ID
- LOVE / IRRB/13/26
- Conditions
- Liver Transplantation (LT), Early Allograft Dysfunction, Primary Non-function, Ischemia-Reperfusion Injury
- Keywords
- liver transplantation, Early Allograft Dysfunction (EAD), Primary Non-Function (PNF), Ischemia-Reperfusion Injury, Liver Graft Viability Assessment
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- The Mediterranean Institute for Transplantation and Advanced Specialized TherapiesUniversity, hospital or other
- Study start
- Dec 2026 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Jun 2029 (estimated)
- First posted
- 29 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Liver transplantation is a life-saving treatment for patients with severe liver disease. Because of the shortage of donor organs, transplant centers increasingly use donor livers that may be more vulnerable to injury and dysfunction. To improve the quality of these organs before transplantation, many centers use hypothermic oxygenated machine perfusion (HOPE or D-HOPE), a technique that preserves the liver under cold, oxygenated conditions. However, there are currently no widely accepted methods to determine whether a liver is functioning well enough during this preservation process.
The purpose of this study is to investigate whether changes observed in liver tissue during hypothermic machine perfusion can help predict how well the transplanted liver will function after surgery. The study will compare liver biopsy samples collected before and after one hour of perfusion and will analyze biological markers released into the perfusion fluid, including markers of mitochondrial injury and inflammation.
The main question this study aims to answer is whether histological changes occurring during hypothermic perfusion, alone or in combination with biochemical biomarkers, can accurately predict liver graft viability and post-transplant outcomes. Researchers will also evaluate whether these data can be used to develop an artificial intelligence-based model to support clinical decision-making during organ preservation.
A total of 150 adult liver transplant recipients receiving donor livers treated with HOPE or D-HOPE will be enrolled at three Italian liver transplant centers. Participants will be followed for 90 days after transplantation to assess liver graft function, graft survival, patient survival, and post-transplant complications.
The results of this study may improve the assessment of donor liver quality before transplantation and help clinicians make more informed decisions about organ use, ultimately increasing the safety and effectiveness of liver transplantation.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HOPE/D-HOPE Liver Transplant Recipients | Experimental | Procedure: Hypothermic Oxygenated Machine Perfusion (HOPE/D-HOPE)Adult liver transplant recipients receiving donor liver grafts preserved with hypothermic oxygenated machine perfusion (HOPE or D-HOPE) prior to transplantation. Liver biopsies and perfusate samples are collected before and during perfusion for histological and biomarker analyses, and participants are followed for 90 days after transplantation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult liver transplant recipients (≥18 years of age).
- Donor liver grafts from either Donation after Brain Death (DBD) or Donation after Circulatory Death (DCD).
- Grafts undergoing hypothermic oxygenated perfusion (HOPE) (HOPE or D-HOPE) for a minimum duration of 1 hour prior to transplantation.
- Availability of two wedge liver biopsy samples: one pre perfusion and one post-perfusion.
- Grafts preserved using standard cold storage protocols and transported in ice-cold Servator C™ solution.
Key exclusion criteria (8 listed)
- Inadequate or fragmented biopsy samples, preventing proper histological evaluation.
- Biopsy samples showing histological features of pre-existing chronic liver disease (e.g., cirrhosis, autoimmune hepatitis, chronic viral hepatitis).
- Liver grafts subjected to normothermic perfusion or other non hypothermic perfusion techniques.
- Organs undergoing experimental or non-standard perfusion protocols.
- Grafts from donors <18 years of age.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hypothermic Oxygenated Machine Perfusion (HOPE/D-HOPE)Standard-of-care hypothermic oxygenated machine perfusion of donor liver grafts before transplantation, with collection of biopsies and perfusate samples for research analyses. | Procedure or surgery | HOPE/D-HOPE Liver Transplant Recipients |
Primary outcome
Graft Survival
Time frame: 90 days after liver transplantation
Graft survival defined as the absence of Early Allograft Dysfunction (EAD) or Primary Non-Function (PNF) following liver transplantation. Histological changes observed between pre-perfusion and post-perfusion liver biopsies will be evaluated for their association with graft outcomes.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypothermic Oxygenated Machine Perfusion (HOPE/D-HOPE) in people with Liver Transplantation (LT) and Early Allograft Dysfunction, run by The Mediterranean Institute for Transplantation and Advanced Specialized Therapies at 3 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ivan Vella (+39 3803403369, ivella@ismett.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Graft Survival (time frame: 90 days after liver transplantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.